Europe is the second largest medical device market, second only to the US and before countries like Japan and Australia. This poses attractive opportunities for international companies trying to enter the European market. However, to be successful, it is essential that companies comply with and are able to meet local requirements and regulations.
European law requires companies marketing medical devices within the European Union, to have a registered place of business in a Member State or to designate a person(s) responsible to act as a European Authorized Representative who is (are) established in the Community. The European Authorised Representative must inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned.
Due to possible conflict of interest with commercial objectives it may make sense not to use distributors as European Authorised Representatives.